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| Sponsor: | University of Medicine and Dentistry New Jersey |
|---|---|
| Collaborator: |
Sunovion |
| Information provided by (Responsible Party): | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00324896 |
Purpose
Parkinson's disease (PD) is the second most common neurodegenerative disease in the US, affecting nearly 1 million Americans. Up to 82% of community dwelling individuals with PD complain of sleep disturbances, typically sleep fragmentation. Despite the high prevalence of sleep problems and their impact on the life of these individuals, there has been, until recently, little research focus on the problem. This will be a multi-site, double blind, placebo-controlled, two arm, parallel group, fixed-dose trial which will last 6 weeks. Seventy patients at four sites (30 at the PI's site and a total of 40 patients at three external sites) will be equally randomized to eszopiclone or placebo. The primary hypothesis is that eszopiclone will be superior to placebo for the treatment of insomnia in patients with Parkinson's disease
| Condition | Intervention | Phase |
|---|---|---|
|
Parkinson's Disease Insomnia |
Drug: eszopiclone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone |
| Enrollment: | 30 |
| Study Start Date: | May 2006 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: eszopiclone
eszopiclone
|
Drug: eszopiclone
eszopiclone
Other Name: Lunesta 2 - 3 mg q HS
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 35 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Other medications with CNS activity that the patient is on at screening, e.g., dopaminergic drugs, B-blockers, etc, will be kept constant throughout the acute phase.
-
Exclusion Criteria:
Patients who are unable to be maintained on their current dose of PD medications throughout the trial.
-
Contacts and Locations| United States, Georgia | |
| Fusion Sleep Center | |
| Suwanee, Georgia, United States, 30024 | |
| United States, New Jersey | |
| The New Jersey Neuroscience Institute | |
| Edison,, New Jersey, United States, 08818 | |
| UMDNJ Robert Wood Johnson Medical School | |
| Piscataway, New Jersey, United States, 08854 | |
| United States, Pennsylvania | |
| University of Pennsylvania Medical School | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Matthew Menza, MD | University of Medicine and Dentistry New Jersey |
More Information
| Responsible Party: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00324896 History of Changes |
| Other Study ID Numbers: | 5581 |
| Study First Received: | May 9, 2006 |
| Last Updated: | January 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Parkinson's insomnia drug eszopiclone placebo |
|
Parkinson Disease Sleep Initiation and Maintenance Disorders Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Sleep Disorders, Intrinsic |
Dyssomnias Sleep Disorders Mental Disorders Eszopiclone Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |